Manager, Medical Writing

Manager, Medical Writing - Regulatory Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full‑Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. WORK HERE MATTERS EVERYWHERE We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong. Job Responsibilities Project-specific management responsibilities for medical writing staff members. Recommends courses of action on salary administration, interviewing and selection, terminations, professional development, performance appraisals, job description preparation, and employee counseling. Works with and advises staff on administrative policies and procedures, technical problems, priorities, and methods. Reviews and edits departmental work products for completeness, accuracy, and overall quality; assumes responsibility for quality of departmental work products. Ensures adherence to Sponsor objectives and that quality standards are maintained. Supports the company’s MW leadership team in the planning, development and implementation of document development strategies and development and presentation of quarterly business updates. Assists with the preparation of budgets and timelines for medical writing activities (full-service clinical development projects and stand-alone medical writing projects) as needed. Assists with budgeting, revenue, invoicing, and forecasting as requested. Assists with budgeting, revenue, invoicing, and forecasting as requested. Contributes to departmental metrics by assisting in the tracking, maintaining and reviewing project metrics. Supports business development by assisting with proposal and costing development as well as bid defenses and customer meetings. Builds and maintain relationships with internal and external customers. Forms, maintains and leads productive cross‑functional working teams, including addressing issues that arise. Reviews performance of medical writing personnel (direct reports). Develops and maintains departmental SOPs and templates and acts as resource for implementation. Participates in the planning, writing, and assembly of medical writing deliverables, as needed. Performs senior reviews of medical writing deliverables, as well as reviews of statistical analysis plans and table/figure/listing. Performs other work‑related duties as assigned. Minimal travel may be required (up to 25%). Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever‑changing environment. Learn more about Syneos Health. Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. Summary Responsible for the task‑specific supervision of the medical writing staff members. Coordinates resources and medical writing activities to ensure that medical writing deliverables are high‑quality, clear and accurate, and meet regulatory standards, customer needs, and internal requirements. 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